Demonstrating the Value, Safety, and Feasibility of Telehealth in Clinical Trials

DESCRIPTION 

The use of telehealth increased rapidly and dramatically as a form of healthcare delivery at the onset of the COVID-19 pandemic. This has created opportunities to reexamine healthcare implementation, particularly when it comes to clinical trials. While telehealth has been integrated into clinical trials in behavioral health and other fields, its use in gynecologic oncology was prohibited by guidelines prior to the pandemic. As these patients are frequently immunocompromised, telehealth presented an opportunity to reduce unnecessary exposure and mitigate infection. However, the use of telehealth for these patients is compelling beyond the pandemic as it could offer options to patients for whom in-person visits are socially and financially burdensome.  

A retrospective cohort study looked at patients enrolled in gynecologic oncology clinical trials at the University of Pennsylvania Health System between March and August 2020 compared to a pre-telehealth period from Sept 2019 through March 2020. They found that utilization of telehealth for these patients did not increase clinical workload, nor contribute to adverse patient outcomes. While these findings were very promising, additional evidence was needed to demonstrate feasibility, safety, and value, both to standardize this as a practice in national protocols and to support reimbursement for telehealth visits used in clinical trials. 

Thus, this study will perform a cost-benefit analysis to demonstrate the value of telehealth in clinical trials by examining spending based on claims data from a pre-telehealth period of September 2019 to March 2020 with a telehealth period of March 2020 to August 2020.  This quantitative analysis will be accompanied by a qualitative component which will include conducting focus group interviews with clinical trial enrollees and chemotherapy providers to assess perceptions of acceptance of and barriers to telehealth in clinical trials. Benefits of this study include potentially changing future clinical trial protocol designs beyond the COVID-19 pandemic and reimagining healthcare delivery for ovarian and other gynecologic cancer clinical trials. 

IMPACT 

This ongoing study will have implications for the feasibility, safety, and value of incorporating telehealth into clinical trials, particularly for gynecologic malignancies. 

PEOPLE 

Emily Ko, MD, MSCR; Genevieve Kanter, PhD; Fiona Simpkins, MD; Justin E. Bekelman, MD; Nandita Mitra, PhD; Katharine Rendle, PhD, MSW, MPH 

FUNDING 

Ovarian Cancer SPORE, National Cancer Institute 

FOCUS 

Clinical Transformation; Health Equity